Laura Rottner, Marc D Lemoine, Lars Eckardt, Katrin Borof, A John Camm, Andreas Goette, Günter Breithardt, Andreas Metzner, Ulrich Schotten, Antonia Zapf, Hein Heidbüchel, Stephan Willems, Harry Crijns, Renate B Schnabel, Larissa Fabritz, Christina Magnussen, Andreas Rillig, Paulus Kirchhof
{"title":"胺碘酮和drone - edarone用于EAST-AFNET早期心律控制的安全性和有效性。","authors":"Laura Rottner, Marc D Lemoine, Lars Eckardt, Katrin Borof, A John Camm, Andreas Goette, Günter Breithardt, Andreas Metzner, Ulrich Schotten, Antonia Zapf, Hein Heidbüchel, Stephan Willems, Harry Crijns, Renate B Schnabel, Larissa Fabritz, Christina Magnussen, Andreas Rillig, Paulus Kirchhof","doi":"10.1007/s00392-025-02637-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Aims: </strong>Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial.</p><p><strong>Methods and results: </strong>Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedarone<sup>never</sup>, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedarone<sup>never</sup> (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28-0.91), age (HR 1.05; CI 1.03-1.07), coronary artery disease (HR 1.84; CI 1.38-2.46) and stable HF (HR 1.66; CI 1.28-2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05-1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13-3.32) were associated with safety outcome.</p><p><strong>Conclusion: </strong>Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4.</p><p><strong>Clinical trial registration: </strong>ISRCTN04708680, NCT01288352, EudraCT2010-021258-20.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4.\",\"authors\":\"Laura Rottner, Marc D Lemoine, Lars Eckardt, Katrin Borof, A John Camm, Andreas Goette, Günter Breithardt, Andreas Metzner, Ulrich Schotten, Antonia Zapf, Hein Heidbüchel, Stephan Willems, Harry Crijns, Renate B Schnabel, Larissa Fabritz, Christina Magnussen, Andreas Rillig, Paulus Kirchhof\",\"doi\":\"10.1007/s00392-025-02637-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aims: </strong>Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial.</p><p><strong>Methods and results: </strong>Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedarone<sup>never</sup>, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedarone<sup>never</sup> (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28-0.91), age (HR 1.05; CI 1.03-1.07), coronary artery disease (HR 1.84; CI 1.38-2.46) and stable HF (HR 1.66; CI 1.28-2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05-1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13-3.32) were associated with safety outcome.</p><p><strong>Conclusion: </strong>Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4.</p><p><strong>Clinical trial registration: </strong>ISRCTN04708680, NCT01288352, EudraCT2010-021258-20.</p>\",\"PeriodicalId\":10474,\"journal\":{\"name\":\"Clinical Research in Cardiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2025-05-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Research in Cardiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00392-025-02637-0\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research in Cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00392-025-02637-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4.
Aims: Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial.
Methods and results: Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedaronenever, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedaronenever (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28-0.91), age (HR 1.05; CI 1.03-1.07), coronary artery disease (HR 1.84; CI 1.38-2.46) and stable HF (HR 1.66; CI 1.28-2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05-1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13-3.32) were associated with safety outcome.
Conclusion: Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4.
期刊介绍：
Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery.
As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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